UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002085
Receipt number R000002249
Scientific Title A Phase II study of laparoscopic gastrectomy for clinical stage II or higher gastric cancer
Date of disclosure of the study information 2009/06/22
Last modified on 2016/12/21 10:23:52

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Basic information

Public title

A Phase II study of laparoscopic gastrectomy for clinical stage II or higher gastric cancer

Acronym

A Phase II study of laparoscopic gastrectomy for stage II or higher gastric cancer (KUGC04)

Scientific Title

A Phase II study of laparoscopic gastrectomy for clinical stage II or higher gastric cancer

Scientific Title:Acronym

A Phase II study of laparoscopic gastrectomy for stage II or higher gastric cancer (KUGC04)

Region

Japan


Condition

Condition

Stage II or higher gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety and efficacy of laparoscopic gastrectomy for stage II or higher gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

incidence of intra- and post-operative complications, postoperative mortality

Key secondary outcomes

overall survival, relapse-free survival,three-year overall survival rate, three-year relapse free survival rate


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Laparoscopic surgery

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Pathologically confirmed gastric cancer
2)Amenable to potentially curative resection
3)Either of below as evaluated by endoscopy and CT scans
a)T2 or higher and lymph node metastasis
b)Tumor larger than 5cm
c)T3 of higher by laparoscopy
4)Age 20 years old or above
5)Informed concent
6)Amenable to general anesthesia

Key exclusion criteria

1)Patient with severe phyciatric disease 2)Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge

Target sample size

73


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiharu SAKAI

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Surgery

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Surgery

Zip code


Address


TEL

075-751-3227

Homepage URL


Email

hokabe@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Surgery
Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Department of Surgery
Graduate School of Medicine, Kyoto University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2009 Year 06 Month 22 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2009 Year 04 Month 08 Day

Date of IRB


Anticipated trial start date

2009 Year 07 Month 01 Day

Last follow-up date

2017 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 06 Month 17 Day

Last modified on

2016 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002249


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name